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Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of ICT (SYMPATHIC)

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ClinicalTrials.gov Identifier: NCT03421392
Recruitment Status : Not yet recruiting
First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

Idiopathic thrombocytopenic purpura (ITP) is the most frequent auto-immune cytopenia. There is no specific biological marker and the diagnosis often results from the exclusion of other differential diagnoses, notably inherited thrombocytopenia.

Recent studies have reported an original platelet destruction mechanism in ITP, by antibody-mediated desialylation of membrane proteins. The detection of platelet sialylation can be readily achieved using flow cytometry. This could provide a new biomarker of ITP, useful to ascertain a diagnosis of ITP and guide towards proper patient management.


Condition or disease Intervention/treatment
Idiopathic Thrombocytopenic Purpura Other: non interventional study

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of Immunologic and Constitutive Thrombocytopenia: Diagnostic and Prognostic Interest.
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019


Group/Cohort Intervention/treatment
Idiopathic thrombocytopenic purpura Other: non interventional study
non interventional study

non immunological thrombocytopenia
patient with constitutive thrombocytopenia, myelodysplastic syndrome, or chemotherapy-induced thrombocytopenia
Other: non interventional study
non interventional study

without thrombocytopenia Other: non interventional study
non interventional study




Primary Outcome Measures :
  1. Assess the difference of sialylation between ITP patients and other causes of thrombocytopenia / controls [ Time Frame: 18 months ]
    a significant decrease in platelets sialylation in ITP patients, measured in flow cytometry with fluorescent Ricinus communis agglutinin


Secondary Outcome Measures :
  1. Prognostic value and therapy [ Time Frame: 18 months ]
    prognostic value of the level of sialylation in ITP patients regarding disease evolution and response of first line treatments and splenectomy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

3 Populations will be recruited in the study:

Number of topics planned:

50 Patients in the PTI group 50 patients in the non-immunological thrombocytopenia group 50 patients in the control group

Criteria

Inclusion Criteria:

  • Adult patients (>18yo) with a diagnosis of ITP (primary acute, persisting or chronical)
  • Adult patients (>18yo) with a diagnosis of non immunological thrombocytopenia (constitutive thrombocytopenia, myelodysplastic syndrome, chemotherapy-induced thrombocytopenia)
  • Adult patients (>18 yo) without thrombocytopenia
  • Enrolled in a Social Security system
  • Having provided informed consent

Exclusion Criteria:

  • Minor patients (<18 yo)
  • Enrolled in another clinical study
  • Having received corticosteroids or polyvalent immunoglobulins in the past 4
  • weeks or anti-platelet therapy or NSAID during the past 7 days
  • Having received platelet transfusion in the past fortnight
  • With proven iron deficiency
  • With drug-induced immune-allergic thrombocytopenia.
  • Pregnant and breastfeeding women,
  • guardian patients, will be excluded from this population.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421392


Contacts
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Contact: Marc Fouassier, Dr 02 40 08 40 49 marc.fouassier@chu-nantes.fr

Locations
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France
Nantes University Hospital Not yet recruiting
Nantes, France, 44093
Contact: Marc Fouassier, Dr    02 40 08 40 49    marc.fouassier@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Marc Fouassier, Dr Nantes University Hospital

Publications:
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03421392     History of Changes
Other Study ID Numbers: RC17_0346
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
constitutive thrombocytopenia
central thrombocytopenia
platelets
sialylation
flow cytometry

Additional relevant MeSH terms:
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Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
Hemorrhage
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Thrombocytopenia
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies